Methylprednisolone for Moderate to Severe Traumatic Brain Injury

NCT07180277 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ZJGSY2025001
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are:

1. 1.Does adding a 5-day course of methylprednisolone improve overall long-term neurological outcome compared with placebo?
2. 2.Does methylprednisolone reduce 6-month mortality or increase the proportion of patients with good neurological recovery?
3. 3.What medical problems do participants experience when receiving methylprednisolone? Researchers will compare methylprednisolone sodium succinate (2 mg/kg/day intravenously for 5 days) with a matching placebo to see if the steroid improves outcomes beyond standard TBI care.
4. 4.Receive either methylprednisolone or placebo once daily for 5 days, added to guideline-directed standard care.
5. 5.Undergo CT scans and neuro-examinations during hospitalization.
6. 6.Return for follow-up visits at 1 month and 6 months after injury for neurological assessments, safety checks, and questionnaires.

Conditions

Traumatic Brain Injury

Keywords

Methylprednisolone; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.

  180 days

Secondary Outcomes (3)

• All-cause mortality

  180 days

• Proportion of patients with good neurological outcome (GOS-E 6-8)

  180 days

• Incidence of adverse events after treatment

  30 days

Study Arms (2)

methylprednisolone

EXPERIMENTAL

Drug: Methylprednisolone (MP)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Placebo

Methylprednisolone (MP) DRUG

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

methylprednisolone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years.
• Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is 4-12.
• Study drug must be initiated within 12 hours after injury.
• Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma.
• Written informed consent obtained from the subject or legally authorised representative.

You may not qualify if:

• Known hypersensitivity to corticosteroids or any contraindication to their use.
• History of diabetes mellitus, or capillary blood glucose \<2.8 mmol/L or \>22.2 mmol/L.
• Shock at admission (systolic blood pressure \<90 mmHg for more than 30 minutes).
• Pregnant or lactating women.
• Participation in another clinical trial within the past 3 months.
• Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.

Sponsors & Collaborators

• Zhangjiagang First People's Hospital: lead

Related Publications (9)

• Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

  PMID: 27654000 BACKGROUND

• Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P; CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004 Oct 9-15;364(9442):1321-8. doi: 10.1016/S0140-6736(04)17188-2.

  PMID: 15474134 BACKGROUND

• He C, Wang Y, Gong W, Zhang S. Targeted Delivery of Acid-Responsive Rutin Nanoparticles Based on Aldehyde Adsorption for the Treatment of Spinal Cord Injury in Rats. ACS Biomater Sci Eng. 2025 Apr 14;11(4):2192-2202. doi: 10.1021/acsbiomaterials.5c00038. Epub 2025 Apr 1.

  PMID: 40167167 BACKGROUND

• Chen X, Chai Y, Wang SB, Wang JC, Yue SY, Jiang RC, Zhang JN. Risk factors for corticosteroid insufficiency during the sub-acute phase of acute traumatic brain injury. Neural Regen Res. 2020 Jul;15(7):1259-1265. doi: 10.4103/1673-5374.272611.

  PMID: 31960811 BACKGROUND

• Zhang B, Bai M, Xu X, Yang M, Niu F, Gao F, Liu B. Corticosteroid receptor rebalancing alleviates critical illness-related corticosteroid insufficiency after traumatic brain injury by promoting paraventricular nuclear cell survival via Akt/CREB/BDNF signaling. J Neuroinflammation. 2020 Oct 25;17(1):318. doi: 10.1186/s12974-020-02000-2.

  PMID: 33100225 BACKGROUND

• Liu Z, Yang Y, He L, Pang M, Luo C, Liu B, Rong L. High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis. Neurology. 2019 Aug 27;93(9):e841-e850. doi: 10.1212/WNL.0000000000007998. Epub 2019 Jul 29.

  PMID: 31358617 BACKGROUND

• Zhang Y, Xiao S, Zhu L, Gan X, Huang Y, Dan F, Chen J, Zhou R, Tang W, Liu J, Liu Z. Effect of Low-dose Methylprednisolone in Promoting Neurological Function Recovery After Spinal Cord Injury: Clinical and Animal Studies. Spine (Phila Pa 1976). 2025 Jul 15;50(14):965-974. doi: 10.1097/BRS.0000000000005269. Epub 2025 Jan 29.

  PMID: 39876698 BACKGROUND

• Zheng C, Li R, Shen C, Guo F, Fan D, Yang L, Zhang L, Chen A, Chen Y, Chen D, Zi W, Guo C, Nguyen TN, Albers GW, Campbell BCV, Qiu Z, Hu Z. Methylprednisolone as Adjunct to Thrombectomy for Acute Intracranial Internal Carotid Artery Occlusion Stroke: Post Hoc Secondary Analysis of the MARVEL Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459945. doi: 10.1001/jamanetworkopen.2024.59945.

  PMID: 39964685 BACKGROUND

• Wang B, Zhang Q, Liu C, Chen X. Counteracting immunodepression by extracellular matrix hydrogel to promote brain tissue remodeling and neurological function recovery after traumatic brain injury. Biomaterials. 2025 Jul;318:123181. doi: 10.1016/j.biomaterials.2025.123181. Epub 2025 Feb 8.

  PMID: 39970603 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-07